A Long-term Follow-up of the HIV-NAT Cohort

HIV Infections Clinical Trial

Official title: A Long-term Follow-up Study for HIV-infected Individuals Who Have Participated in HIV-NAT Study Protocols

Status Recruiting

Clinical Trial Summary

With HIV/AIDS increasingly considered a chronic disease, 24-, or 48-week data from antiretroviral studies are no longer sufficient. Only with long-term follow-up and outcome data will shed some much-needed light on the answers of questions that have stumped us for several years. Data from a large observational cohort of patients treated with combination antiretroviral therapy will provide further insights into the long-term safety and durability of various antiretroviral therapeutic approached, the efficacy of HIV viral load and CD4 cell counts as predictors of disease progression and mortality, and the importance of adherence.

Clinical Trial Description

Primary Objective:

To collect and evaluate long-term clinical outcomes of HIV infected participants previously enrolled in HIV-NAT trials.

Secondary Objective:

To Assess:

1. Long-term consequences of initiation of antiretroviral as predicted by baseline CD4 cell count and/or baseline plasma HIV RNA level

2. Incidence of lipodystrophy and other metabolic complications in three different groups of patients initially treated with NRTI-based regimens, NNRTI-based regimens, or PI-based regimens

3. Class-specific incidence of lipodystrophy and metabolic complications such as d4T versus AZT, nevirapine versus efavirenz and individual PIs (IDV, SQV, Kaletra, and atazanavir)

4. Resistance profiles in patients on different antiretroviral regimens

5. Long-term consequences of antiretroviral agents on cardiovascular, renal, hepatic, and endocrine function, skin, gastrointestinal system and urogentital tract

6. Incidence of opportunistic infections or malignancy including hepatocarcinoma in patients with HIV/HCV or HIV/HBV co-infection

7. Immune recovery syndrome

8. Adherence to different antiretroviral regimens

9. Quality of life ;

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infections

• NCT number: NCT00411983
• Study type: Observational
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: Anchalee Avihingsanon, MD, PhD
• Phone: 66 2 2557334-5
• Email: anchalee.a@hivnat.org
• Status: Recruiting
• Start date: November 2002
• Completion date: December 2030